captopril FDA Alerts

The FDA Alert(s) below may be specifically about captopril or relate to a group or class of drugs which include captopril.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for captopril

Angiotensin-converting enzyme inhibitor (ACE inhibitors) drug class

Jun 7, 2006

Audience: Reproductive and other healthcare professionals, patients

[Posted 06/07/2006] The New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The FDA-approved labels recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. ACE inhibitor drugs are labeled pregnancy category C for the first trimester of pregnancy, and are labeled pregnancy category D during the second and third trimesters. Healthcare professionals should take these findings into consideration with other information about a patient’s medical situation when prescribing ACE inhibitors.

At this time, based on this one observational study, the FDA does not plan to change the pregnancy categories for ACE inhibitors. FDA will work with the Agency for Healthcare Quality and Research to identify other potential sources of data that will help determine the degree of risk associated with first trimester exposures to these drugs.

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